Regulatory Affairs Lead
Job Description
We are seeking an experienced Regulatory affairs professionals with 5+ years of experience in regulatory affairs, specifically for KSA operations based in UAE. The ideal candidate should have a proven track record in managing regulatory processes, liaising with SFDA, and leading a team to ensure compliance with all regulatory requirements in KSA.
Key Responsibilities
- Lead & manage the regulatory affairs team to ensure timely and accurate submission of regulatory documents, including product registrations, renewals, labelling updates, and variations in compliance with SFDA regulations.
- Act as the primary liaison with SFDA and other KSA regulatory bodies, ensuring efficient communication and resolution of regulatory issues.
- Preparation and submission of CTD & eCTD in alignment with SFDA guidelines.
- Ensure compliance with KSA regulatory requirements for health supplements, medical devices, pharmaceuticals, cosmetics, and other product categories.
Key Skills
Key Skills
- SFDA processes, product registration, licensing, and submission workflows.
- Expertise in managing the company registration with SFDA, ensuring all required listings, permits, and approvals are current and accurate
- Regulatory Submissions in CTD & eCTD formats.
- Strong knowledge of requirements for food supplements, pharmaceuticals, cosmetics, and medical devices in KSA.
Familiarity with procedures for obtaining and renewing distribution and marketing authorizations from SFDA.
